Reported Jul 27, 2016 · Terminated
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code…
Pharmedium Services, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pharmedium Services, LLC · 150 N Field Dr Ste 350 · Lake Forest, IL · 60045-2506
Is this the product you have?
- 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 Service Code 2T8232 , Lot Number 160970019C , Exp. Date 5/7/2016 2 Service Code 2T8878 , Lot Number 160450193M , Exp. Date 5/6/2016 3 Service Code 2T8878 , Lot Number 160470227M , Exp. Date 5/8/2016 4 Service Code 2T8878 , Lot Number 160590187M , Exp. Date 5/19/2016 5 Service Code 2T8878 , Lot Number 160630026M , Exp. Date 5/23/2016 6 Service Code 2T8878 , Lot Number 160700162M , Exp. Date 5/31/2016 7 Service Code 2T8878 , Lot Number 160710004M , Exp. Date 5/31/2016 8 Service Code 2T8878 , Lot Number 160740228M , Exp. Date 6/4/2016 9 Service Code 2T8878 , Lot Number 160750111M , Exp. Date 6/4/2016 10 Service Code 2T8878 , Lot Number 160900226M , Exp. Date 6/20/2016 11 Service Code 2T8878 , Lot Number 161080176M , Exp. Date 7/8/2016 - Amount recalled
- 384 Medical Cassettes
This recall covers 75 products
The agency filed one notice per product. You are reading one of them; the other 74 are below.
62 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
This product could cause temporary or reversible health problems — stop using it.
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